FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/04/085793 [Registered on: 28/04/2025] Trial Registered Prospectively
Last Modified On: 28/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Unani 
Study Design  Single Arm Study 
Public Title of Study   A STUDY TO EVALUATE EFFECTIVENESS OF UNANI COMPOUND DRUG IN KINDEY STONE 
Scientific Title of Study   A Prospective, Open label, Single-Arm Study to Evaluate the Efficacy of Unani Formulations in the Management of Hasah aL-Kulya (Renal calculus)  
Trial Acronym  NILL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR TABISH SHAMSHI 
Designation  PG SCHOLAR 
Affiliation  DEPARTMENT OF ILMUL JARAHAT STATE TAKMEEL UTTIB COLLEGE AND HOSPITAL  
Address  DEPARTMENT OF ILMUL JARAHAT STATE TAKMEEL UTTIB COLLEGE AND HOSPITAL
NEAR RAMABAI RALLY STHAL BIJNOR ROAD AURANGABAD TIRAHA lucknow
Lucknow
UTTAR PRADESH
226002
India 
Phone  9457607786  
Fax    
Email  Tabish.raja@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rakhshinda Baig 
Designation  Reader Department of Ilmul Jarahat 
Affiliation  DEPARTMENT OF ILMUL JARAHAT 
Address  DEPARTMENT OF ILMUL JARAHAT STATE TAKMEEL UTTIB COLLEGE AND HOSPITAL
DEPARTMENT OF ILMUL JARAHAT STATE TAKMEEL UTTIB COLLEGE AND HOSPITAL NEAR RAMABAI RALLY STHAL BIJNOR ROAD AURANGABAD TIRAHA
Lucknow
UTTAR PRADESH
226002
India 
Phone  9415337189  
Fax    
Email  baigrakhshi12@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Abdul Quavi  
Designation  Professor and H.O.D 
Affiliation  DEPARTMENT OF ILMUL JARAHAT 
Address  DEPARTMENT OF ILMUL JARAHAT STATE TAKMEEL UT TIB COLLEGE AND HOSPITAL
DEPARTMENT OF ILMUL JARAHAT STATE TAKMEEL UTTIB COLLEGE AND HOSPITAL NEAR RAMABAI RALLY STHAL BIJNOR ROAD AURANGABAD TIRAHA
Lucknow
UTTAR PRADESH
226002
India 
Phone  9455077880  
Fax    
Email  quavinium@gmail.com  
 
Source of Monetary or Material Support  
State Takmeel uttib College and hospital Lucknow Near Ramabai Rally Sthal Bijnaur Road Aurangabad Tiraha 226002 
 
Primary Sponsor  
Name  State Takmeel uttib College and hospital Lucknow 
Address  Near Ramabai Rally Sthal Bijnaur Road Aurangabad Tiraha 226002 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR TABISH SHAMSHI  State Takmeel uttib College and hospital Lucknow  Department of Ilmul Jarahat Near Ramabai Rally Sthal Bijnor Road Aurangabad Tiraha 226002
Lucknow
UTTAR PRADESH 
9457607786

Tabish.raja@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutinal Ethics commitee State Takmeel Uttib College and Hospital Lucknow  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N200||Calculus of kidney,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
Intervention  Prepared Unani compound Formulation Dawa-e-Gurda include the following ingredients: Hajrul yahood 200gm, sang-e-sar-e-mahi 200gm, jawakhar 200gm, sat-e-barzad 200gm, Alu balu 200gm, Tukhm-e-sarawali 200gm, Habb-e-kaknaj 200gm, Kaf-e-darya 200gm, Habb-ul-qilt 200gm  Sufoof(Powder) 3gm orally BD For 6 weeks 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Diagnosed case of Hasah al kulya ( Renal calculus ) upto 10 mm ( Radiological evidence )
Patients who have agreed to sign the informed consent form and follow up the protocol . 
 
ExclusionCriteria 
Details  Patients diagnosed as stone size more than 10 mm or location other than kidney
. urinary bladder outlet obstruction
Known cases of Diabetes mellitus and any serious systemic illness.
Patients having any type of malignancy
Pregnant and lactating women.
Any acute or chronic kidney disease.
Mentally retarted patient.
Patient having severe flank pain, gross haematuria,
severe hydroureteronephrosis and deranged RFT
Patient who fail to give consent 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Pain in flank region
Burning micturition
Haematuria
Nausea/ vomiting
Frequency of micturition 
Day 0, 15th 30th
45th  
 
Secondary Outcome  
Outcome  TimePoints 
USG whole abdomen
Urine R/M
Blood urea and serum creatinine 
0 and 45th day 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   10/05/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Renal stone or calculus is one of the most common disease of urinary tract. it occurs more frequently in men than in women, white than in black and it shows familial predisposition. 
Urinary stone is a stone like body composed of urinary salts bound together by a colloidal matrix of organic material it consist of a nucleus around which concentric layers of urinary salts are deposited. 
the primary purpose of protocol is to outline standardized procedure for diagnosing, managing and treating renal stone patient.
The protocol aims to provide a clear framework for assessing symptoms, evaluating the severity of the condition , and implementing appropriate interventions to improve patient outcomes and quality of life. this may include life style modification, Diet modification, Medication depending on the severity of the symptoms.
Urinary calculi has its roots deeply embedded in urological literature. treatment have changed drastically over the centuries, from lithotripsy to open surgical procedure to removal of stone. 
Nephrolithiasis or renal calculus affect approximately 15% population worldwide and about 2.3 % population of India. it affects all age groups from less than 1 year of age to more than 70 years of age, with male female ratio 2:1.
Urinary stone are among one of the most significant cause of morbidity and end stage renal failure. its rate of recurrence in male is about 70-81%  and in female 47-60%.
Despite of various technological advent ages in minimal invasive therapy in treatment of renal stone like ESWL, Percutaneous  nephrolithotomy the management of renal stone remain challenge due to high cost, adverse effect and complication of minimal invasive technique.
The study aims to assess whether these Unani compound formulations can offer significant benefit in alleviating symptoms, improving urinary function and removal of stone.
 
Close